On April 7, 2020 Perrigo Company plc (NYSE; TASE: PRGO) reported preliminary unaudited first quarter 2020 net sales and provided GAAP and non-GAAP operating income for the first quarter (Press release, Perrigo Company, APR 7, 2020, View Source [SID1234556170]).

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Perrigo CEO and President, Murray S. Kessler commented, "While our first priority is the health and wellbeing of our employees and their families, all of us at Perrigo recognize the importance of access to our self-care and health-care products during this global health crisis. For perspective, Perrigo’s Consumer Self-Care Americas business supplies more than half of the acetaminophen (Tylenol equivalent) volume in the United States in addition to many other essential products. During the first quarter, Perrigo continued to experience strong growth across all business segments, while also benefiting from a dramatic surge in demand in March related to the COVID-19 pandemic. Through a herculean effort by our employees, especially our production employees around the world, we were able to supply most of the demand. As a result of these efforts and other factors, Perrigo first quarter net sales increased 14% versus prior year, with organic net sales(1)(2) higher by 11%. First quarter non-GAAP operating income is estimated to be $220 million to $225 million versus $203 million in the prior year quarter. This includes new supplemental bonuses to demonstrate our appreciation to front-line production employees for their dedication and hard work in delivering our essential products to consumers and patients during these unprecedented times."

Preliminary Unaudited First Quarter 2020 Net Sales & Operating Income Range
Consolidated first quarter net sales were approximately $1.3 billion, an increase of 14% compared to the prior year quarter. Excluding exited businesses(2) and the impact of currency, net sales increased 18%. Organic net sales were up 11%.

Worldwide Consumer first quarter net sales were approximately $1.1 billion, an increase of 16% compared to the prior year quarter. Excluding exited businesses and the impact of currency, net sales increased 21%. Organic net sales were up 12%. As a reminder, Worldwide Consumer is comprised of the Consumer Self-Care Americas segment, Consumer Self-Care International segment and corporate.

Consumer Self-Care Americas segment first quarter net sales were approximately $700 million, an increase of 20% compared to the prior year quarter. Excluding exited businesses and the impact of currency, net sales increased 25%. Organic net sales were up 15%.

Consumer Self-Care International segment first quarter net sales were approximately $380 million, an increase of 9% compared to the prior year quarter. Excluding exited businesses and the impact of currency, net sales increased 14%. Organic net sales were up 8%.

Rx segment first quarter net sales were approximately $260 million, an increase of 6% compared to the prior year quarter, which benefitted from the U.S. Food and Drug Administration approval and launch of generic albuterol sulfate inhalation aerosol. This more than offset the negative net sales impact of price erosion on testosterone gel 1.62%, which launched in the prior year with 180-day market exclusivity.

The Company estimates first quarter GAAP operating income of $140 million to $145 million, versus $102 million in the prior year quarter. The Company estimates non-GAAP operating income for the quarter of $220 million to $225 million versus $203 million in the prior year quarter. Both the reported and non-GAAP estimates include $4 million in supplemental production employee bonuses.

The Company currently intends to release complete first quarter 2020 financial results during the last week of April 2020. Given the volatility and uncertainty of the current operating environment, the Company does not expect to modify full-year guidance at that time.

See attached Appendix for reconciliation of adjusted (non-GAAP) to reported (GAAP) financial measures.

(1) Organic net sales growth excludes the 2019 acquisition of Ranir, exited businesses and the impact of currency.

(2) Exited businesses refers to the divested animal health business in the prior year period, which was previously included in the Consumer Self-Care Americas segment, and the divested Canoderm prescription product in the Nordic region in the prior year period, which was previously included in the Consumer Self-Care International business. In 2019, net sales of Canoderm were $13 million with adjusted operating income of $8 million.

ON April 7, 2020 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) reported entering into an agreement with a fund affiliated with an institutional investor providing for a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, pursuant to which Idera has sold shares of common stock together with accompanying warrants to purchase an additional shares of common stock, for aggregate gross proceeds of $5.0 million (Tranche 1). The price per share paid for the common stock was $1.52 per share (Press release, Idera Pharmaceuticals, APR 7, 2020, View Source [SID1234556169]). The common stock warrants have an exercise price of $2.28 per share, a term of three years and are exercisable after the Company receives stockholder approval and files a charter amendment to sufficiently increase the Company’s authorized shares of common stock to cover the exercise of the common stock warrants issuable under the agreement (Tranche 1 Initial Exercise Date).

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Pursuant to the agreement, the investor may, at their option, make a further investment of an additional $5.0 million to purchase shares of common stock (or common stock equivalents), together with accompanying common stock warrants to purchase additional shares of common stock (Tranche 2). The common stock purchase will be $1.76 per share. The common stock warrants, if issued, will have an exercise price of $2.71 per share, a term of three years and are exercisable after the later of their issuance date and the Tranche 1 Initial Exercise Date. Idera has the right to refuse Tranche 2 if, prior to receipt of notice from the investor, the closing price of Idera’s common stock is $3.01 or higher for any 20 consecutive days after June 30, 2020. The investor’s option to invest in Tranche 2 expires on December 30, 2020.

To the extent Tranche 2 is closed and inclusive of proceeds from the exercise of warrants issuable in this private placement, the Company may receive up to $20.7 million in gross proceeds. The Company plans to use the proceeds from the financing primarily to fund the completion, of the ongoing ILLUMINATE-301 clinical trial of its lead product, tilsotolimod, for the treatment of anti-PD-1 refractory metastatic melanoma. The Company also plans to use the subsequent proceeds, if exercised, to fund the potential NDA filing and commercial launch of tilsotolimod along with the ongoing ILLUMINATE-206 trial, and for general corporate purposes.

The shares of common stock (or common stock equivalents) and warrants sold in the private placement have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.clinicaltrials.gov.

On April 7, 2020 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported certain unaudited preliminary first quarter financial results (Press release, Integra LifeSciences, APR 7, 2020, View Source [SID1234556168]). The company also announced that it will release full first quarter 2020 financial results on Thursday, May 7, 2020, prior to market open. Given the existing uncertainty related to COVID-19, the company is withdrawing its guidance for the first quarter and full-year 2020 previously issued on February 19, 2020.

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Preliminary First Quarter Revenue Results and Second Quarter Outlook

First quarter 2020 reported revenue is expected to be in the range of $352 million to $354 million, representing a decline of approximately -1.9% on a reported basis and approximately -0.5% on an organic basis compared to the first quarter of 2019. While the first two months of the quarter were in line with management expectations, surgical procedures declined significantly in March as healthcare providers reallocated resources to address the increasing demands caused by COVID-19. The preliminary results set forth above are unaudited and remain subject to completion of the Company’s financial closing procedures.

The Company expects the ongoing impact from restrictions on surgical procedures and shelter-in-place policies to have a more substantial negative impact on second quarter performance. Though we currently are unable to determine the magnitude of the impact, we are continuing to monitor, assess and respond to the situation, and we will provide an update on May 7, 2020.

Response to COVID-19 (Coronavirus)

Integra’s primary focus during this global crisis remains on supporting patients, providing customers with life-saving products, and protecting the well-being of its employees.

In February, the Company implemented contingency plans to address the operational impact of COVID-19 and ensure ongoing operations, focusing primarily on the Asia Pacific region. During March, the rapid and evolving spread of the virus resulted in an unprecedented challenge to the global healthcare industry. In response to the challenge, the Company has expanded its contingency plans to enable its manufacturing and distribution sites around the world to continue operating at levels required to meet demand and to provide for the safety of its employees. In addition, the Company has initiated significant cost-savings measures. Those measures include freezing hiring, eliminating overtime, ending third-party services and temporary contractor relationships, and rapidly reducing capital expenditures and discretionary spending including travel, events, and marketing programs. The Company will provide more details on these cost-savings measures on May 7, 2020. Given the ongoing uncertainty to revenues and operating costs surrounding COVID-19, the first quarter 2020 and the full-year 2020 financial guidance provided by the Company on February 19, 2020 should no longer be relied upon.

The Company remains confident that the markets in which it competes remain attractive over the long term, and that growth will return as the impact of COVID-19 diminishes.

Integra’s financial position and liquidity remain strong. In early February, the Company renegotiated the terms of its $2.2 billion bank facility, extended the maturity of its credit agreement by two years to 2025, and issued a $575 million convertible note with a 0.5% fixed interest rate. Inclusive of these 2020 transactions, the 2019 year-end balances would have been a cash balance of $321 million, net debt of $1.3 billion and a bank leverage ratio of about 3.0 times.

First Quarter 2020 Financial Results Conference Call
The Company will release full first quarter 2020 financial results on Thursday, May 7, prior to market open. In conjunction with the earnings release, Integra’s management team will host a conference call at 8:30 a.m. ET.
The live call is accessible by dialing (800) 263-0877 and using the passcode 5089204. A simultaneous webcast of the call will be available via the Company’s website at www.integralife.com.
A webcast replay of the call can be accessed through the Investor Relations homepage of Integra’s website at www.integralife.com. A replay of the call will be available until May 12, 2020 by dialing (888) 203-1112 and using the passcode 5089204.

On April 7, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report first quarter 2020 results on Wednesday, April 22, 2020, before the market opens (Press release, Quest Diagnostics, APR 7, 2020, View Source [SID1234556166]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The company also will provide an update on the impact of the COVID-19 pandemic. On March 31, 2020, Quest Diagnostics filed a Current Report on Form 8-K with the Securities and Exchange Commission to outline the impact of the pandemic on its operating results, cash flows and financial condition and withdraw its previously announced guidance for full year 2020.

The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 800-839-1170 for domestic callers or 402-998-0559 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 22, 2020 until midnight Eastern Time on May 6, 2020.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On April 7, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab (anti-PD-1) for the treatment of cervical cancer (Press release, Agenus, APR 7, 2020, View Source [SID1234556165]). This designation was based on comprehensive data that support the potential for balstilimab to address a significant unmet medical need. Agenus expects to file 2 BLAs this year for accelerated approval of the combination of balstilimab and zalifrelimab and balstilimab monotherapy in metastatic cervical cancer.

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"We are pleased to have now been granted Fast Track designation by FDA for both balstilimab as a monotherapy and in combination with zalifrelimab (anti-CTLA-4) in recognition of the high unmet medical need in second line cervical cancer," said Dr. Anna Wijatyk, Head of Clinical Development, Agenus. "The Fast Track designation confers important benefits, including the potential eligibility for a Priority Review, and we are excited to work with the FDA to quickly advance novel agents for women who suffer from metastatic cervical cancer."

Agenus has updated data from a pre-planned interim analysis revealing robust and durable activity for balstilimab and zalifrelimab in patients with relapsed or refractory metastatic cervical cancer. The data for the combination demonstrated 26.5% objective response rates (ORR) (4 CRs, 5 PRs) which are durable (median not yet reached) and for balstilimab monotherapy, a 14.3% ORR (1 CR, 5 PRs) in an all-comer, non-biomarker selected population of patients with refractory cervical cancer who have failed prior platinum chemotherapy with or without bevacizumab.

Fast Track designation1 is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a Biologic Licensing Application (BLA).